Associate Director, Formulation & Drug Product Development

Terns Pharmaceuticals•Foster City, CA

3d•$184,500 - $203,000

About The Position

Terns Pharmaceuticals is a clinical-stage oncology company committed to developing transformative therapies that improve the lives of patients with cancer. As we advance from early clinical development to late-stage programs, we are expanding our CMC organization to support late-stage development and commercial readiness. The Associate Director, Formulation & Drug Product Development will serve as a key technical leader within the CMC organization, driving formulation strategy and execution for small‑molecule programs progressing from clinical development through commercialization. This role will lead formulation design, late‑stage process development, tech transfer, and oversight of global CDMO partners to ensure the timely delivery of robust, high‑quality drug products. The ideal candidate is a hands‑on formulation expert with extensive experience in solid oral dosage form development, a proven ability to solve complex technical challenges, and a demonstrated track record of advancing programs through Phase 3, validation, and commercial readiness.

Requirements

Advanced degree preferred: Ph.D. or M.S. in pharmaceutics, pharmaceutical sciences, chemical engineering, or related discipline.
8-10+ years of industry experience in small‑molecule formulation and drug product development, including substantial late‑stage experience (Phase 3 through commercialization).
Demonstrate expertise in developing and characterizing solid oral dosage forms, including tablets, capsules, and modified‑release systems.
Proven experience leading process development, scale‑up, technical transfer, and PPQ/commercial readiness activities with global CDMOs.
Strong understanding of QbD principles, risk assessment, and establishing robust control strategies for commercial drug products.
Experience supporting global regulatory submissions, including IND, IMPD, NDA/MAA, and interactions with regulatory authorities.
Hands-on experience with formulation technologies such as solubility enhancement (e.g., amorphous dispersions, lipid systems), particle engineering, and stability optimization.
Strong technical problem‑solving skills with the ability to lead root cause investigations and develop scientifically sound solutions.
Demonstrate ability to collaborate effectively Drug Substance, Analytical Development, Quality, Regulatory, and Supply Chain teams.
Excellent organizational, communication, and project management skills, with the ability to manage multiple programs and CDMOs simultaneously.
Experience mentoring scientists or managing external technical resources.
Ability to thrive in a fast‑paced, growth‑stage biotech environment and contribute to building a world‑class CMC organization.
Strategic thinker with technical depth and operational execution capabilities.
Excellent communication, collaboration, and vendor management skills.
Comfortable operating in a fast-paced, entrepreneurial biotech environment.
Willingness to travel up to 35%, including to CDMO and manufacturing sites for vendor assessment, qualification, audits, and manufacturing oversight as needed.

Responsibilities

Strategic & Technical Leadership Work with CMC leadership to define and execute formulation and drug product development strategies across all stages of development, with particular emphasis on late‑stage development and commercial readiness.
Develop and optimize small-molecule oral solid dosage formulations and scalable manufacturing processes to ensure product quality, stability, and reliable clinical supply.
Establish and refine specifications, control strategies, and critical quality attributes aligned with global regulatory expectations and lifecycle management considerations.
Serve as a subject matter expert in addressing formulation challenges (e.g., solubility enhancement, stability, polymorph/form selection, modified‑release technologies, fixed‑dose combinations).
Provide scientific leadership in risk assessments, root-cause investigations, and product characterization activities.
Program Execution & Vendor Management Lead pre-formulation, formulation development, process development, scale‑up, clinical manufacturing, and technology transfer for late-stage programs, particularly for solid oral dosage forms.
Manage multiple development activities across global CDMOs, ensuring scientific rigor, operational excellence, adherence to timelines, and optimization of cost of goods.
Provide on-site support (“person-in-plant”) during key manufacturing campaigns to ensure successful execution.
Provide technical oversight and guidance to CDMO partners during regular development and project management meetings.
Cross-Functional Collaboration Partner closely with Drug Substance, Analytical Development, Quality, Regulatory, and Supply Chain teams to support process validation, PPQ strategies, and commercial readiness.
Support global regulatory submissions (IND, IMPD, NDA/MAA), responses to health agency queries, and contribute to briefing packages and health authority interactions.
Support supply chain planning and oversight to ensure uninterrupted clinical supply and successful transition to commercial operations.
Communicate program updates, risks, and decisions to senior leadership and key stakeholders with clarity and precision.
Leadership & Team Development Collaborate across CMC and cross-functional teams to ensure integrated development strategies, proactive risk mitigation, and uninterrupted supply of clinical and commercial product.
Mentor and guide formulation scientists, contractors, and external consultants supporting internal development programs.
Contribute to building a high‑performing and collaborative CMC organization that supports the company’s progression toward commercialization.
Demonstrate a proactive, solution‑oriented leadership style that fosters excellence, accountability, and integrity.